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Going Deeper Into Rare Disease, GSK Takes Reins of Amicus Fabry Program

This article was originally published in The Pink Sheet Daily

Executive Summary

Even with Phase III trial delays, Glaxo pays $60 million upfront for worldwide rights to Amigal and takes a minority stake in its developer.

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Amicus' Oral Fabry Drug Priced To Compete Against Traditional ERT

FDA approved Galafold under accelerated approval, paving the way for the launch of the first oral therapy to treat a subset of patients with the rare condition Fabry disease. Amicus priced Galafold at $315,000 per year.

FDA Reversal Gives Amicus Renewed Hope For US Oral Fabry Launch

Amicus plans to file migalastat for Fabry disease in the US in the fourth quarter, after FDA gave the greenlight, reversing a decision last year to require an additional Phase III study.

FDA Reversal Gives Amicus Renewed Hope For US Oral Fabry Launch

Amicus plans to file migalastat for Fabry disease in the US in the fourth quarter, after FDA gave the greenlight, reversing a decision last year to require an additional Phase III study. Additional information includes European submission data and post-launch RWE.

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